New Zealand is home to many “exotic” species, some introduced by early Maori9 settlers, others
by later European colonists. The introduction of exotic species was encouraged in the 19th
Century through the establishment of Acclimatisation Societies (McDowall, 1994); in more recent years, however, government policy has not only classified many of these species as pests in need of eradication, but also halted the entry of any further new species (Jay & Morad, 2006). Instead of framing New Zealand as having impoverished ecosystems in need of improvement, emphasis is now placed on protecting the distinctive indigenous flora and fauna found in this geographically isolated island state. As a result, “biosecurity” measures have become firmly embedded in New
19 Zealand’s social and legislative practices, and the current biosecurity regime has been described as one of the most comprehensive in the world (Barker, 2008). Biosecurity practices are evident in everyday New Zealand life, from washing fishing equipment to halt the spread of Didymo,10 to
discarding fruit before disembarking from an international flight to prevent the introduction of new pests. They are also viewed by some as necessary to the economic growth of New Zealand, given its reliance on primary production.
Few developed countries are as highly dependent on agricultural trade as New Zealand: we export 80–90 percent of the food we produce. Meat, dairy, live animal and wool exports account for 12, 30, 0.5 and 2 percent respectively of all export earnings, with a total of more than 20 billion dollars a year. Farming industry bodies see a major biosecurity event as one of the biggest risks they face. (Bingham, 2013, p. 3)
The Biosecurity Act (1993) and the Hazardous Substances and New Organisms Act (HSNO Act, 1996) provide the legislative framework for the practices by which New Zealand maintains its biological borders. They each operate in complimentary ways: the Biosecurity Act prevents the unintentional introduction of new organisms into New Zealand (through, for example, imported shipping crates) while the HSNO Act regulates the intentional introduction of new organisms into New Zealand (for example, to import an animal to live in a zoo) (Barker, 2008). GMO research represents a potential biosecurity threat because it involves the creation or importation of an organism not already present in New Zealand: a GMO is therefore defined as a “new organism” under both the Biosecurity Act (1993,Part 1, section 2) and the HSNO Act (1996, Part 1,
section2A). As such, there are overlaps between these two pieces of legislation with regards to GMO research and there is therefore also some degree of collaboration between the two government agencies charged with responsibilities under each Act. The Environment Risk Management Authority (ERMA) was the decision-making authority under the HSNO Act (1996) until this role was taken over by the Environmental Protection Authority (EPA) on 30th June 2011
(see section 2.4 below for discussion). The Ministry of Agriculture and Forestry (MAF) was charged with responsibilities under the Biosecurity Act (2003) until these were incorporated into the new Ministry of Primary Industries (MPI) on 30th April 2012. MAF (now the MPI) also bears
some responsibility for enforcing decisions made by ERMA (now the EPA) under the HSNO Act. The case study material presented in this thesis deals mainly with the functions of ERMA and
10 Didymo is an algal species that is responsible for water quality issues in New Zealand rivers. It is currently
20 MAF, but I will make reference to the EPA and MPI in relation to more recent events or
documents that have also been used.
The overlap between these two Acts and the collaboration between MAF and ERMA is particularly evident in the establishment and control of containment facilities. A containment facility is a place “for holding organisms that should not, whether for the time being or ever, become established in New Zealand” (Biosecurity Act, 1993, section 2). While such facilities can be used for a number of purposes ranging from zoo enclosures to medical laboratories, there are two broad categories of containment facility used in GMO research. Physical Containment (PC) facilities are used for indoor GMO research, and are classified numerically from 1-4 according to the level of containment they provide: a PC1 facility is operated according to the least stringent of conditions11. Outdoor research is conducted in a field trial facility, for which there is no sub-
classification denoting the level of containment provided. Aside from these differences, both indoor and outdoor containment facilities are legally defined as providing the means for “containment” under the HSNO Act (1996; see RCGM, 2001, p.122).
A place can only be classified as a containment facility if, in accordance with section 39 of the Biosecurity Act (1993), it applies to MAF for approval. This approval will be granted after an assessment of both the physical structure of the facility and the Quality Management System (QMS) that describes in detail what the facility is and how it is to be used. The QMS is essentially a written document which covers all aspects of the structure and operation of the containment facility. For indoor facilities this is usually in the form of a containment manual that applies to the whole research campus (see e.g. Lincoln University, 2011). For outdoor facilities, this is specific to a particular field test, and is set by ERMA in the conditions attached to a field test approval (see e.g. ERMA, 2008a, Appendix 1). The QMS for a containment facility is written in accordance with one or more of five joint MAF/ERMA standards covering the containment of living things: microorganisms and cell cultures; vertebrates; invertebrates; zoo animals; and plants. Exactly which of these standards are of relevance to a particular facility depends on the nature of the work being done inside it. Indoor facilities often contain more than one research project so may be certified according to a number of standards, whereas outdoor facilities have only been used for GMO field tests of vertebrates or plants and would therefore only be certified according to one of these standards.
11 Most facilities in New Zealand offer either PC1 or PC2 levels of containment. There are only a few PC3
21 In addition to the joint MAF/ERMA standards, laboratories are also subject to the requirements of the Australian/New Zealand Standard 2243.3 Safety in Laboratories. Part 3: microbiological safety and containment (AS/NZS 2243.3), an international standard for laboratory work that has been written into New Zealand law. In the early days of GMO research, AS/NZS 2243.3 functioned alone in providing the guidelines for laboratory work; it wasn’t until the early 2000s that ERMA and MAF developed the five standards that covered the specific needs of different types of containment facilities12. AS/NZS 2243.3 still provides the most detailed account of the
requirements for laboratory containment: it is not only a much longer document than any of the MAF/ERMA standards, it is also referred to by them as a source of information: “AS/NZS 2243.3: 2002 specifies the minimum requirements of physical containment (PC)” (MAF Biosecurity New Zealand and ERMA New Zealand, 2007a, p. 21).
The MAF/ERMA standards specify the physical and operational requirements that must be met for a place to be certified as a containment facility. The physical requirements for containment facilities for research involving plants (see MAF Biosecurity New Zealand and ERMA New Zealand, 2007b), for example, state that both indoor and outdoor facilities must restrict the access of people to and from the site, and also ensure that no viable genetic material is able to leave it (see section 8.1). Laboratories must be constructed with concrete floors and mesh coverings over openings such as windows and vents so that rodents and insects cannot enter (see section 8.1.2). The specific construction requirements for field boundaries are given by ERMA in the controls attached to any field test consent (see section 8.1.3). Both types of facility must restrict access to authorised personnel who have specified roles in the research project (see section 7.1.2); visitors are only allowed entry if they are accompanied by one of these people (see section 8.1.1.1 and 8.1.3.1). Access logs must be used to document the flow of people in and out of both types of facility (see section 8.1.1.1 and e.g. ERMA, 2008a, Appendix 1, control 2.1).
The MAF/ERMA standards also stipulate the operational requirements for a containment facility. As part of these requirements provision must be made for an effective training programme that teaches people how to work in a containment facility (see e.g. MAF Biosecurity New Zealand and ERMA New Zealand, 2007b, section 7.1.3). This in turn requires the appointment of a person responsible for designing, implementing, and documenting staff training. Research institutions make different arrangements for this role depending on their staffing structure. At Lincoln University, which has a number of PC1 and PC2 laboratories on one campus, this role is
22 undertaken by the Biological Safety Officer (BSO) with some input from the Health and Safety Manager. Laboratory supervisors also provide training relevant to work in a specific laboratory (see Lincoln University, 2011).
The operational requirements for containment facilities also make specific reference to documents and record-keeping processes that must accompany GMO research. Figure 2.3 (below) lists the different documents that are held on file for any given GMO at Lincoln University.
Biosecurity clearance (BACC’s)
ERMA approvals (hold for min 7yrs after completion) Export certificates
Import permits
Log of activities with respect to plants and animals Major and minor changes to facility
Restricted cultures spreadsheet
Restricted imported animals spreadsheet Restricted imported Biologicals spreadsheet Restricted imported plants spreadsheet Transfer permits
Transfer tracking record
Figure 2.3 A list of the different documents that must be held on record in relation to a GMO. (Taken from Lincoln University, 2011, p. 128)
While the above list provides no detail on the content and purpose of these documents, it can be taken as an indication of the large amount of written material that is required in the conduct of GMO research. This observation, in addition to other details of the physical and operational requirements for containment facilities, will be examined in detail in Chapter 7.